1. Field of the Invention
The present invention relates to a fixation apparatus for a medical device, and in particular, a fixation apparatus for attaching a medical device to a patient.
2. Background Art
In the field of medicine, inadvertent needle sticks are an omnipresent hazard to both medical personnel and patients. One way to reduce the probability of an accidental needle stick is to reduce the number of needles used in medical procedures. For example, surgical staples have been shown to be a viable alternative to traditional sutures for closing certain incisions. The use of anchoring devices such as surgical staples as a mechanism for attaching a medical device to a patient is, however, far from fully developed. For example, a venous or arterial catheter may be inserted into a patient and left there for an extended period of time. In order to inhibit accidental removal of the catheter, a catheter clamp, or even the catheter hub, is often attached to the patient's skin. The catheter hub is a device used with multi-lumen catheters that allows multiple input lines to feed into a main catheter line. The other ends of the input lines may be attached to sources of medicinal liquids that are provided to the patient through the main catheter line. The catheter hub generally has a fixed location relative to the point of entry of the catheter line into the patient. In contrast, a catheter clamp is a device that is generally movable relative to the catheter line, so it may be conveniently attached to the line near its point of entry into the patient. The attachment of the catheter clamp or catheter hub to the patient provides strain relief, such that if the catheter line is inadvertently tensioned, the strain will be at the point of attachment to the patient, and the end of the catheter will not be dislocated.
To facilitate attachment of a catheter hub or catheter clamp to a patient, one or more holes are typically provided in the device so that medical personnel can suture the hub or clamp directly to the patient's skin. As an alternative to the suture, it has been recommended that a surgical staple be used, utilizing the same hole that was specifically designed to receive the sutures. This system has generally proven inadequate, in that installing a surgical staple through a hole that was specifically designed to accommodate sutures is awkward, and to the extent that medical personnel are successful at installing a staple through such a hole, the attachment may be inadequate. For example, it may be necessary to not only staple both sides of the hub or clamp to provide adequate fixation, it may be necessary to use more than one staple in each hole. This means that medical personnel may be required to perform the cumbersome operation of stapling through a suture hole four or more times to secure one catheter line.
Therefore, a need exists for a fixation apparatus for attaching a medical device, such as a catheter clamp, to a patient that facilitates the use of non-suture anchoring devices, such as surgical staples, to be used as the primary or sole form of fixation, and that allows such anchoring devices to be easily attached while still securely affixing the medical device to the patient.